MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD EUFLEXXA 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problem Off-Label Use (1494)

Patient Problems Pain (1994); Nodule (4551)

Event Date 02/01/2020

Event Type  Injury  

Event Description

Panniculitis [panniculitis]. Pain in the injection site [injection site pain]. Waited another two months before getting the 2nd injection [wrong schedule]. Off label use [unapproved schedule according to core label] [off label use]. Case (b)(4) is a serious spontaneous case received from a consumer via the fda in united states. This report concerns a female patient of unknown age, who experienced panniculitis and pain in the injection site during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration 5 injections, for arthritis from 2020 to 2020. The patient reported she had arthritis in her knees and was given a steroid injection for the pain and was later told by her doctor about euflexxa. The patient was told that she would be given three injections, once a week for three weeks. On an unspecified date in 2020, the patient received the first injection and reported that she experienced pain in the injection site and complained to her doctor about the pain and it was decided to wait for another week before getting the second injection. Due to this procedure happening during the covid lock down, the patient waited another two months before getting back to the doctor's office for her third injection. The patient was then told that she would have to start all over and stated that she had a total of five euflexxa injections. The patient reported that after taking these injections, she started to develop lumps in her right calf and a few days later the same lumps in her left leg. The patient visited her doctor and a biopsy was taken from her left leg and was diagnosed with panniculitis. The patient believed that the panniculitis was a result of the euflexxa injection and that she was reacting to the euflexxa gel. The panniculitis was medically significant. Action taken with euflexxa was not applicable. At the time of this report, the outcome of panniculitis was unknown, the outcome of pain in the injection site was unknown. Concomitant medication was not reported. The event panniculitis was reported as serious. The event pain in the injection site was reported as non-serious. At the time of reporting the case outcome was unknown. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: not related. Sender´s comment: due to the administration of euflexxa as intra-articular and the genesis of panniculitis is it considered very unlikely that the euflexxa caused the panniculitis, hence company causality as not related. Other case numbers: internal # - others
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mw5097449. This ae occurred in united states and concerns the medical device euflexxa. Please report to your local health authority if required by local law. This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the medical device directive/ because it did not occur in a eu + efta country and did not result in a corrective action by the manufacturer. No corrective action was done by the manufacturer or requested by regulators.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; bee'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054
• MDR Report Key: 10874346
• MDR Text Key: 217628947
• Report Number: 3000164186-2020-00015
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 11/20/2020 Patient Sequence Number: 1